Decentralized Trial in Atrial Fibrillation Patients

NCT ID: NCT04471623

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-03-12

Brief Summary

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The purpose of this study is to validate an approach to decentralize, or virtualize, the clinical trial experience for enrolled subjects, through the coordinated use of multiple digital health and telehealth technologies. The study aims to validate the feasibility, acceptability and best practices of coordinating/integrating several individual digital health technologies to achieve execution of high compliance, cost-efficient, and scientifically sound clinical trials.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DeTAP Study App and Home Devices

Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies

Group Type EXPERIMENTAL

Use of DeTAP App and Home Devices

Intervention Type BEHAVIORAL

DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff

Interventions

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Use of DeTAP App and Home Devices

DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Atrial Fibrillation documented (health record diagnosis or EKG) within the past year and taking an oral anticoagulant (OAC) medication for stroke prevention
* Uses a smart phone daily and is willing to use apps and home devices for the study
* Agreeable to use a Televisit method to conduct all study visits from trial team

Exclusion Criteria

* Active angina, stable or unstable, requiring urgent cardiovascular functional risk stratification (stress testing or catheterization) or intervention. Or has congestive heart failure that is not compensated or in which the subject is not euvolemic, as determined by the treating MD
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
* Does not speak English
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Rajesh Dash, MD PHD

Associate Professor of Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajesh Dash, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford

Stanford, California, United States

Site Status

Countries

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United States

References

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K Josan, A Touros, C Petlura, V Parameswaran, U Grewal, M Senior, T Viethen, H Mundl, C Seninger, J Luithle, K Mahaffey, M Turakhia, R Dash, Validation of a pandemic-proof, decentralized cardiovascular trial: scalable design produces rapid recruitment, high engagement and protocol adherence in DeTAP (Decentralized Trial in Afib Patients), European Heart Journal, Volume 42, Issue Supplement_1, October 2021, ehab724.3177, https://doi.org/10.1093/eurheartj/ehab724.3177

Reference Type BACKGROUND

Sarraju A, Seninger C, Parameswaran V, Petlura C, Bazouzi T, Josan K, Grewal U, Viethen T, Mundl H, Luithle J, Basobas L, Touros A, Senior MJT, De Lombaert K, Mahaffey KW, Turakhia MP, Dash R. Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP). NPJ Digit Med. 2022 Jun 28;5(1):80. doi: 10.1038/s41746-022-00622-9.

Reference Type RESULT
PMID: 35764796 (View on PubMed)

Other Identifiers

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57019

Identifier Type: -

Identifier Source: org_study_id

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